PatelAshmi

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    2NDYEAR RESEARCH ELECTIVE RESIDENTS JOURNAL Volume IV, 1999-2000

    number of cells. In sum, fenugreek seeds and karela juice have been shown to exert significant

    hypoglycemic activity in studies involving animals and small numbers of humans. Acute consumption

    within the context of studies and chronic consumption as part of the diet, in various parts of the world, has

    demonstrated these products to be safe.

    B. Study Design and Statistical Analysis

    The study will be a randomized, placebo-controlled, double-blinded, clinical trial, with 4 parallel

    arms. The study will require a total of 100 type II diabetic patients who will be randomly assigned to 4

    groups (A-D) of 25 patients. All groups will receive 4 weeks of an isocaloric, control diet, followed by

    12 weeks of the diet plus an intervention or diet plus placebo. Group A will receive ground fenugreek

    seeds plus placebo juice capsules. Group B will receive karela juice capsules plus placebo seeds. Group

    C will receive both fenugreek seeds and karela juice capsules. Group D will receive placebo seeds and

    placebo juice capsules. The primary endpoint measured will be hemoglobin A1C. The secondary

    outcomes will be mean fasting and postprandial glucose levels, as well as a fasting serum cholesterol

    panel. HgbA1C will be measured at baseline, after the 4 weeks of control diet, and after 12 weeks of

    intervention. Patients will also measure fasting glucose daily and postprandial (2 hours post breakfast,

    lunch, and dinner) glucose once a week, during the diet and diet plus intervention period. The mean

    fasting and postprandial glucoses for each patient will be calculated during each period. The difference inHgbA1C between the post diet and post intervention values will be calculated for each patient. The mean

    of this difference in each group will be compared to the mean of the difference in the placebo group.

    Similarly, the change in the mean fasting and postprandial glucose levels will be calculated for each

    patient. The mean of this change in each group will be compared to the mean of the change in the

    placebo group. A fasting cholesterol panel will be obtained at baseline, after the 4 week diet period, and

    after the 12 weeks of intervention period. The change in lipids of each group will be compared to the

    placebo group, in a fashion similar to that of HgbA1C and serum glucose levels.

    The data will be analyzed using the unpaired t-tests. The study requirement of 25 patients per

    group is based on a power of 80% and a p value of 0.01 for detecting a difference in mean HgbA1C of

    1.0%, which would be a clinically relevant outcome.

    C. Study Procedures

    Patients will receive nutrition counseling on an individual basis to design an isocaloric diet

    consisting of 50% carbohydrates, 30% fat, and 20% protein. Patients will keep daily records of their food

    intake and review these data with the nutritionist on a bi-weekly basis. The goals are for each patient to

    maintain a stable weight and have a similar diet during the diet alone and diet plus intervention phases.

    Patients will also be instructed to use a One-Touch glucometer to measure fasting and postprandial

    glucose levels and will record these values. Karela juice will be extracted from fresh karela using a

    commercial juice extractor, after removal of the seeds. The juice will be concentrated by rotary

    evaporation to yield a tenfold concentrate. 50 cc's of fresh juice will be concentrated to 5 cc's and

    subsequently packaged in 2 capsules. 5 cc's of a placebo liquid of similar will be similarly encapsulated.

    Each patient will receive 2 capsules of the karela juice or the placebo with breakfast, lunch, and dinner.

    Fenugreek seeds will be defatted to remove their bitterness. 25 grams of ground fenugreek powder, whichis odorless and tasteless, will be incorporated into unleavened wheat bread (chapati). Each patient will

    consume 1 piece of bread with fenugreek or 1 piece of placebo bread, with breakfast, lunch, and dinner.

    D. Study Drugs

    Fenugreek seeds and karela juice are natural plant products. Both have been consumed

    chronically as food products and as medicines for centuries throughout India, China, and Africa. Such

    wide use as well as administration in studies involving animals and humans, has shown them to be well

    Columbia University College of Physicians and Surgeons 133

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    2NDYEAR RESEARCH ELECTIVE RESIDENTS JOURNAL Volume IV, 1999-2000

    tolerated and without deleterious effects. Fenugreek has been reported to cause occasional cases of

    diarrhea and upset stomach.

    E. Medical Devices

    None

    F. Study Questionnaires

    None

    G. Study Subjects

    Eligible patients will be men and women, age 25-75, BMI

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    2NDYEAR RESEARCH ELECTIVE RESIDENTS JOURNAL Volume IV, 1999-2000

    Columbia University College of Physicians and Surgeons 135

    The study will likely yield two natural, safe products for the treatment of type II diabetes. These

    will likely serve as adjuncts to standard therapy and will ultimately provide improved control of diabetes

    for the study subjects and for society as a whole. Patients will also receive nutrition counseling and

    instruction of blood glucose monitoring as well as information of the diabetes as a disease, its

    complications, and how they can be prevented.

    N. Alternative Therapies

    Sulfonylureas , metformin, and insulin. The risks and benefits of these therapies have been wellstudied and described.

    O. Compensation to Subjects

    None

    P. Costs to Subjects

    None

    Q. Minors as Research Subjects

    R. Radiation or Radioactive Substances

    None

    S. References

    1. Leatherdale BA et al, Improvement in glucose tolerance due to Momordica charantia ,

    British Medical Journal 282: 1823-24.

    2. Day C et al, Hypoglycaemic Effect of Momordica charantia Extracts, Planta Medica 56:426-29.

    3. Ahmed I et al, Effects of Momordica charantia fruit juice on islet morphology in the

    pancreas of the streptozotocin-diabetic rat, Diabetes Research and Clinical Practice 40: 145-

    51.

    4. Sharma RD et al, Effect of fenugreek seeds on blood glucose and serum lipids in Type I

    diabetes, European Journal of Clinical Nutrition 44: 301-06.

    5. Sharma RD, Effect of fenugreek seeds and leaves on blood glucose and serum insulin

    responses in human subjects, Nutrition Research 6: 1353-64.

    6. Madar Z et al, Glucose-lowering effect of fenugreek in non-insulin dependent diabetics,

    European Journal of Clinical Nutrition 42: 51-54.

    7. Madar Z et al, Fenugreek as a means of reducing postprandial glucose level in diabetic rats,Nutrition Reports International 29: 1267-73.